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The Effectiveness and Safety of the Trial of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor

To Study the Effectiveness and Safety of the Trail of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor: a Multi-center, Prospective, Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05215041
Enrollment
510
Registered
2022-01-31
Start date
2022-01-28
Completion date
2025-06-30
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Labor, Trial of Labor After Cesarean, Vaginal Birth After Cesarean

Brief summary

This study is a multi-center, prospective, observational clinical trial study. 510 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with one prior cesarean section after spontaneous labor who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation after spontaneous labor but without vaginal labor contraindications will be enrolled. After spontaneous labor for 24h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.

Interventions

OTHERNon intervention

If the vaginal delivery is failed after spontaneous labor for up to 24h, they will receive cesarean section

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Volunteers sign the informed consent 2. Age: 20-40 years; 3. Singleton, a cephalic presentation; 4. No contradiction to vaginal delivery; 5.39\ 42 weeks; 6.Spontaneous labor

Exclusion criteria

1. Konwn contraindication to vaginal delivery or severe complications; 2. Multiple gestation; 3. Uterine malformation; 4. Severe psychiatric disorder; 5. Without family's support.

Design outcomes

Primary

MeasureTime frameDescription
Vignial birth rate24 hoursAfter spontaneous labor for up tp 24h, the mode of delivery will be konwn and recorded.

Countries

China

Contacts

Primary ContactJiang Ziyan, Ph.D
zyjiangchm@163.com13512534017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026